What is NDC 83831-134?

83831-134 is the product NDC for Lutrate Depot (leuprolide acetate) kit, listed with the FDA by Avyxa Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Lutrate Depot (Leuprolide acetate).

Avyxa Pharma, LLC, NDC labeler code 83831. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lutrate Depot?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lutrate Depot NDC 83831-134 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83831-134Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83831-0134Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
83831-134-01	8383101340183831013401	1 KIT in 1 CARTON (83831-134-01) * 2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22) * 2 mL in 1 SYRINGE (83831-135-02)Marketed from Mar 26, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Lutrate Depot
Generic name (nonproprietary): leuprolide acetate
Dosage form: Kit
Labeler: Avyxa Pharma, LLCNDC labeler code 83831
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 205054
Marketing start: Mar 26, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 83831-134_d4332d30-8a83-4118-88bb-3c49851837b6SPL ID d4332d30-8a83-4118-88bb-3c49851837b6SPL set ID 3a6d1373-17d9-4289-b62f-d299ffe55831RxCUI 2606516, 2709448

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N483831013401 followed by a unit qualifier and the quantity

Package 83831-0134-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jun 3, 2025.

Indications (excerpt from the label)

LUTRATE DEPOT 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer. LUTRATE DEPOT is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Treatment of advanced prostate cancer. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83831-134

What is NDC 83831-134?: 83831-134 is the product NDC for Lutrate Depot (leuprolide acetate) kit, listed with the FDA by Avyxa Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lutrate Depot (Leuprolide acetate).
Who is the labeler?: Avyxa Pharma, LLC, NDC labeler code 83831. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lutrate Depot?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 205054

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 205054
Product	Strength	Form · route	Labeler	Product NDC
Leuprolide Acetate Depotleuprolide acetate	—	Kit	CIPLA USA INC.	69097-909

Lutrate Depot (Leuprolide acetate) NDC 83831-134